Introduction: The SAFE Dualcore Universal Nail is an interlocking nail with an antibiotic cement core. We compared the clinical and radiological results with a standard interlocking nail for treating open fractures of the tibia.
Materials and Methods: Prospective, controlled cohort trial, including thirty patients with open fractures of the tibia. Patients were divided into two groups according to the treatment method: Group I (STD), consisting of 14 patients treated by delayed interlocking standard nailing, after an antibiotic treatment and bed rest. Group II (SAFE) had 16 patients treated with an interlocking intramedullary nail with a core of polymethyl methacrylate cement with antibiotics. Five of these were temporarily stabilized with an external fixator. We added vancomycin (2 g) and flucloxacillin (2 g) to the bone cement in the core of the nail. The two groups were similar on demographic data (age, gender), fracture, and extent of the wounds (P > 0.05). The mean follow-up was 2.4 years (5 months to 4 years) for the STD group and 2.1 years (4 months to 3 years) for the SAFE group.
Results: Fifteen of the 30 patients had positive cultures, including 13 cases growing Enterobacter, Enterococcus, Pseudomonas, and methicillin-susceptible Staphylococcus aureus (MSSA) groups. The infection rate was significantly more in STD at 43% (6/14 patients) compared to SAFE 6% (1/16 patients), (P = 0.02). Healing times was significantly more for STD group, at an average of 7.5 months (3-18 months) compared to 4.5 months (2-8.5 months) for the SAFE group (P = 0.02). The complication rate was 64% (9/14) in the STD group and 25% (4/16) for the SAFE, including the infection rate, a statistically significant difference (P = 0.03). The six infected STD nailing cases were salvaged with antibiotic coated cement nails, five of which healed. Infection recurred in the sixth case and was treated with the Ilizarov method.
Conclusion: SAFE nails had lesser infection, faster consolidation, and fewer complications compared with standard nails in treating open fractures of tibia. We can choose the type and dose of antibiotics eluted by the nail. The SAFE DualCore Universal nail is mechanical stable as well as biologically active. It allows fixation of intermediate bone segments, shortens hospital stay, healing time, and reduces the cost of treatment.
Level of Evidence: Level III.